Document Detail

Performance characteristics of a no-pretreatment, random access sirolimus assay for the Dimension RxL clinical chemistry system.
MedLine Citation:
PMID:  19303402     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: Current therapeutic drug monitoring methods for sirolimus require a manual pre-treatment step and batch analysis. We describe and validate a no-pretreatment, random access sirolimus assay for the Dimension RxL clinical chemistry system from Siemens Healthcare Diagnostics Inc. DESIGN AND METHODS: Whole blood samples from renal transplant patients prescribed sirolimus were analyzed by the LC-MS/MS reference method, Abbott IMx and Dimension RxL methods in accordance with CLSI recommendations. RESULTS: The Dimension sirolimus assay had a functional sensitivity of 2.0 ng/mL and repeatability and within-laboratory imprecision less than 12.6% at 3 ng/mL and less than 5% at 11-12 ng/mL. Least squares linear regression demonstrated the following relationships: RxL=1.20(LC-MS/MS) - 0.70, r=0.95 and RxL=1.33(IMx) - 0.75, r=0.96. CONCLUSIONS: The Dimension sirolimus assay correlates well with the LC-MS/MS reference and IMx immunoassay methods and has the advantage of random access analysis without a manual pre-treatment step.
Mark A Cervinski; Show-Hong Duh; Karl G Hock; Jeffery Gray; Tie Q Wei; Daniel C Kilgore; Robert H Christenson; Mitchell G Scott
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Validation Studies     Date:  2009-03-19
Journal Detail:
Title:  Clinical biochemistry     Volume:  42     ISSN:  1873-2933     ISO Abbreviation:  Clin. Biochem.     Publication Date:  2009 Jul 
Date Detail:
Created Date:  2009-06-15     Completed Date:  2009-08-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0133660     Medline TA:  Clin Biochem     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1123-7     Citation Subset:  IM    
Department of Pathology and Immunology, Division of Laboratory and Genomic Medicine, Washington University School of Medicine, Box 8118, 660 S. Euclid Avenue, St. Louis, MO 63110, USA.
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MeSH Terms
Biological Assay / methods*,  standards*
Chemistry, Clinical / methods*,  standards*
Drug Monitoring / methods*,  standards*
Sirolimus / blood*
Reg. No./Substance:

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